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NCT Number: NCT07235540

More Representative Vaginal Temperature Measurements With a Hyperthermia Pelotte During Hyperthermia Treatments for Gynaecological Cancer.

The goal of this comparative, cross over single centre study is to to determine whether the average measured vaginal temperature during hyperthermia treatment is (clinically) significant different with the use of a pelotte than with a standard vaginal probe. in 27 women treated with external beam radiotherapy and deep hyperthermie for gynaecological cancer.. The primary endpoint is measured average vaginal temperatures with pelotte versus a standard vaginal probe.

The secondary endpoints are: reproducibility of catheter placement, patient comfort, inter-fractional spread of the vaginal temperature and the average vaginal temperature at the tip (0 cm) and 2 cm from the tip with pelotte and a standard vaginal probe.

Participants will be treated at least two time with a pelotte and two times with a standard vaginal probe. Participants will be asked to fill in a short questionnaire three times per treatment (before, during and after treatment). A total of 12-15 questionnaires will be completed by the participants over the four to five treatments.

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Key information

Conditions

Gynaecologic Cancer Body Temperature Changes Heat Stress Disorders Hyperthermia Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Erasmus MC

Rotterdam, South Holand, 3015GD, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Women aged 18 or older diagnosed with gynaecological cancer
  • Indication for EBRT with DHT
  • Written informed consent

Exclusion criteria

  • Any condition potentially interfering with the understanding of the study requirements, informed consent procedure and completion of questionnaires
  • If the vaginal lumen is <4 cm.

Treatment and study plan

Pelotte

Device

The pelotte is a medical device. It is a round rod made of PTFE - polytetrafluoroethylene (figure 3). The top 7 cm has a diameter of 20 mm and the bottom 13 cm has a diameter of 11 mm. One disposable catheter for temperature measurements will be attached to the pelotte with tape. This catheter will be placed ventrally on the pelotte. A thermometer will be placed in this catheter. This thermometer will measure the vaginal temperatures. A condom is then placed over the pelotte and the catheter before insertion into the patient.

At least two treatment will be with pelotte and at least 2 with a standard vaginal probe.

Primary outcomes

  1. • Average vaginal temperature during DHT treatments with pelotte and with a standard vaginal probe.

    Time frame: approximately seven weeks from the intake with the radiation oncologist to the last treatment administration

    To compare if the average vaginal measured temperature is significant different with a pelotte versus the standard vaginal probe

Secondary outcomes

  1. Inter-fractional reproducibility of the catheter placement in depth and position with pelotte and with a standard vaginal probe.

    Time frame: Approximately seven weeks from the intake with the radiation oncologist to the last treatment administration

    For each treatment, the free length of the vaginal probe is measured from the outer labia to the probe tip. This distance is subtracted from 293 mm to determine the internal depth of the vaginal probe. In the control room, the depth is determined based on the temperature measurements. If the measured temperature falls below 36 degrees Celsius at a certain point (e.g., 8 cm from the tip), this point is considered the probe depth. These values are then compared to assess whether there is a difference in reproducibility between treatments using the pelotte and treatments using only a vaginal probe.

  2. Inter-fractional variance in measured vaginal temperatures with pelotte and with a standard vaginal probe.

    Time frame: Approximately seven weeks from the intake with the radiation oncologist to the last treatment administration.

  3. Patient-reported comfort with pelotte and with a standard vaginal probe, as assessed using the 'Vragenlijst Hyperthermie Pelotte' questionnaire

    Time frame: Approximately seven weeks from the intake with the radiation oncologist to the last treatment administration.

  4. Average vaginal temperature at the measurement points of the tip (0 cm) and two cm from the tip of the catheter with pelotte and with a standard vaginal probe.

    Time frame: Approximately seven weeks from the intake with the radiation oncologist to the last treatment administration.

Study contacts

Contact information is provided by the study sponsor or research team.

A.F. Rink, PhD student

CONTACT

[email protected]

+31107041314

G.H Westerveld, Dr.

CONTACT

[email protected]

+31107041249

Sponsors and collaborators

Lead sponsor

Dr. G.H. (Henrike) Westerveld

Other

Registry information

Official study title

The Use of a Hyperthermia Pelotte to Acquire More Representative Vaginal Temperature Measurements During Deep Hyperthermia Treatments for Gynaecological Cancer; a Comparative Cross-over Study.

Acronym: ORIENTATE

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Nov 19, 2025
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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